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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Influenza A And Influenza B Multiplex Nucleic Acid Assay
510(k) Number K263035
Device Name CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel (includes Influenza A/B Typing Kit, Influenza A Subtyping Kit, Influenza A(H5) Subtyping Kit, and Influenza B Lineage Genotyping Kit)
Applicant
Centers for Disease Control and Prevention
1600 Clifton Rd.
Atlanta,  GA  30329
Applicant Contact Marie Kirby
Correspondent
Centers for Disease Control and Prevention
1600 Clifton Rd.
Atlanta,  GA  30329
Correspondent Contact Melissa Ivey
Regulation Number866.3980
Classification Product Code
OZE  
Subsequent Product Codes
NSU   OEP   OOI   OQW  
Date Received08/31/2026
Decision Date 09/30/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 Yes
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